Abstract

Background The optimal anti-thrombotic treatment after transcatheter aortic valve replacement (TAVR) remains a matter of debate. Dual antiplatelet therapy (DAPT) is recommended but single antiplatelet therapy or oral anticoagulation (OAC) are frequently used according to the patient profile. Whether this may impact clinical outcome is unknown.

Method and objectives: FRANCE-TAVI is a prospective multicenter nation-wide French registry. Our objectives were to identify independent correlates of long-term all-cause mortality and early bioprosthetic valve dysfunction (BVD, defined as increased prosthetic gradient ≥10 mmHg or new gradient ≥20 mmHg).

Results Of 12,804 patients included between January 1, 2013 and December 31, 2015, 11,469 (age 82.8±0.07 years old [mean±SE], logistic Euroscore 17.8±0.1%, mean duration follow-up was 495±3.5 days) were alive at discharge with known antithrombotic treatment and were analyzed for mortality. 2555 had at least 2 echocardiographic evaluations and were eligible of BVD assessment. One third of patients had a history of atrial fibrillation and the same proportion had OAC at discharge (n=3836). Neither aspirin nor clopidogrel were independently associated with mortality. Male gender (adj HR 1.63 [1.44-1.84], p<0.001), history of atrial fibrillation (adj. HR 1.41 [1.23-1.62], p<0.001) and chronic renal failure (adj. HR 1.37 [1.23-1.53], p<0.001) were the strongest independent correlates of mortality. Anticoagulation at discharge (adj. OR 0.54 [0.35-0.82], p=0.005) and a non-femoral approach (adj. OR 0.53 [0.28-1.02], p=0.049) were independently associated with lower rates of BVD, while chronic renal failure (adj. OR 1.46 [1.03-2.08], p=0.034) and prosthesis size ≤23mm (adj. OR 3.43 [2.41-4.89], p<0.001) yielded higher risk of BVD.

Conclusions Gender, renal failure and atrial fibrillation, impacted the most mortality at 3-year follow-up. In contrast anticoagulation (mostly given for atrial fibrillation) decreased the risk of BVD after TAVR.

We evaluated whether oral anticoagulation therapy was an independent correlate of long-term survival and early bioprosthetic valve dysfunction (BVD) in 11,469 patients who underwent successful Transcatheter Valve Implantation. One third was on oral anticoagulation at discharge mainly for the prevention of cardioembolic stroke. Anticoagulation at discharge (adj. OR 0.54 [0.35-0.82], p=0.005) and prosthesis size ≤23mm (adj. OR 3.43 [2.41-4.89], p<0.001) were the strongest independent correlates of BVD. Gender, renal failure and atrial fibrillation, impacted the most mortality at 3-year follow-up. However, anticoagulation at discharge remained a correlate of mortality, independently of atrial fibrillation, despite the strong correlation between the two factors.

Dr. Le Breton has received speaker fees from Edwards Lifesciences and Medtronic.

Dr. Eltchaninoff has served as a proctor for and received lecture fees from Edwards Lifesciences. Dr. Lefevre has served as a proctor for Edwards Lifesciences and Abbott.

Dr. Leprince has served as a proctor for Medtronic.

Dr. Souteyrand has served as a consultant to Medtronic, St. Jude Medical, Abbott, and Terumo.

Dr. Iung has received consulting fees from Boehringer Ingelheim; and has received a speaker fee from Edwards Lifesciences.

Dr. Vicaut has received consulting or lecture fees from Abbott, Bristol-Myers Squibb, Celgene, Daiichi-Sankyo, Eli Lilly, Fresenius, European Cardiovascular Research Center, LFB, Hexacath, Medtronic, Novartis, Pfizer, Sanofi, and Sorin; and grants to his institution (APHP) for clinical trials from AstraZeneca, Boehringer-Ingelheim, and Sanofi.

All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Funding: Edwards Lifesciences and Medtronic partly funded the FRANCE-TAVI registry. Edwards Lifesciences and Medtronic had no role in data management, data analysis, or writing of the manuscript. The study was supported by the ACTION Study Group.

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